I read in my Philadelphia Inquirer today that the FDA is lifting the ban on the use of silicone breast implants for breast reconstruction and augmentation surgery. Fourteen years after being pulled from the market amid fears of debilitating physical ailments caused by leakage from or rupture of the devices, the purported medical “watchdog” in the US has agreed to give women what they are supposedly “clamoring for.”

FDA ends ban on silicone-gel breast implants

Two companies’ products are safe but not without risk, the agency said in giving its approval.

By Andrew Bridges

Associated Press

WASHINGTON –

The government ended a 14-year virtual ban on silicone-gel breast implants yesterday despite lingering questions, making the devices available to tens of thousands of women who have clamored for them.

The Food and Drug Administration approved the implants for women 22 and older, or those undergoing breast-reconstruction surgery, but warned that patients probably would need at least one additional operation, because the implants do not last a lifetime.

The decision clears implants made by two California manufacturers, Inamed Corp. – now part of Allergan Inc. – and Mentor Corp.

“There is reasonable assurance that Allergan and Mentor silicone-gel breast implants are safe and effective, and there is adequate information to enable women to make informed decisions,” said Dr. Daniel Schultz, the FDA’s medical-device chief.

Mentor called the decision a “historic moment,” and Allergan said the decision created new options for women.

The twin approvals came with conditions, including that the companies complete 10-year studies on women who have already received the implants, to study leaks, and begin new decade-long studies of the safety of the devices in 40,000 women.

Shultz called the implants “one of the most extensively studied medical devices. We now have a good understanding of what complications can occur and at what rates.”

The FDA warned that the implants did not lack risk and that women might not immediately know if their implants break and silicone begins oozing into their breasts. That means women will need regular MRI exams for the rest of their lives to catch those so-called silent ruptures. Patients will have to be given special brochures that explain these risks.

The FDA decision opens the implants to much wider use by women seeking to reconstruct or augment their breasts. Since 1992, the silicone implants had been available only as part of research studies.

Silicone-gel breast implants first went on the market in 1962, before the FDA required proof that all medical devices be safe and effective. Thirty years later, they were banned amid safety concerns.

At the time, there were worries about a possible connection to diseases, including cancer and lupus. Alarming cases of ruptures added to the concern.

Since then, most studies have failed to find a link between silicone implants and disease.

The rupture issue persists: The implants eventually must be removed or replaced, according to the FDA. A 2000 Institute of Medicine report found rupture rates as high as 77 percent.

Women whose silicone implants ruptured have reported years of pain, swelling, and other symptoms that they attribute to the devices.

Some researchers also worry that the platinum used to manufacture the implants can seep into the body and cause harm. The FDA says there is no evidence of that.

Proponents say silicone-gel implants look and feel more natural than do those filled with saline, or salt water. Those implants are sold without restrictions.

Breast implants have grown in popularity for augmentation, despite a history of lawsuits. Last year, 291,000 women had their breasts surgically enlarged in the United States, a 37 percent increase since 2000, according to the American Society of Plastic Surgeons.

The popularity of implants for reconstructive surgery shrank over the same five-year period by 29 percent, to 58,000 procedures. Last year, 39,000 women had their implants removed.

Impants didn’t make their first appearance until 1962; amazingly, a few, short years following Mattel’s introduction of the Barbie doll. Hmmm. So, Barbie was given a totally unrealistic bustline and women learned to desire to emulate that. Ken, on the other hand, was endowed with nothing more than a pubic bone and that’s okay. Well, Ken may be far more realistic after all.

Here’s my thought…equality for all.

Let’s give Ken what he “ought” to have. Then men will clamor for silicone penile implants the way women clamor for breast implants. What do you suppose is the size of the average dildo? Maybe 7 – 7 1/2 inches? And what, pray tell, is the penile size of the average American male? Maybe 5 1/2 inches? Let’s give men the opportunity to implant silicone into their bodies for the purpose of making themselves more sexually attractive to women. Women will be happier and men will no longer need to feel self-conscious at urinals. And Ken can finally be sold “fully equipped.”

Men will just have to get periodic MRI scans to detect leaks early. Men will have to deal with consequences such as immune system disorders, intense and painful permanent firmness due to slow, undetected leaks (hey…being firm for life…no downside I can see), having to have their weinies squeezed to pop the hard sacs of fibrous tissue that grow around the implant (or not. Again, the downside is?…)

When men are willing to have this shit shoved into their most precious body part to fill out their jeans better, I’ll be willing to have my size A-plusses slit open to accomodate a couple of canteloupe halves to create a little cleavage. Until then, you can keep your dangerous implants and I’ll keep my little handfuls.